Radiation TherapyRELAXNCT07324577
Effectiveness of Virtual Reality (VR) in the Management of Anxiety for Patients Undergoing Radiotherapy
A study testing Virtual Reality Intervention and Radiation Therapist Survey in people with Radiation Therapy and Virtual Reality, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use and functionality of virtual reality (VR) during radiation therapy treatments for patients with prostate, breast, lung, or head and neck cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiation Therapy, Virtual Reality
- What is being tested?
- Virtual Reality Intervention and Radiation Therapist Survey
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2026to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants planned for radiation therapy for 15 or more treatments with non-neutron generating energies (10 MV or less) per study PI for prostate, breast, lung, or head and neck cancer. Neutrons have the potential to damage the VR headset device and are generated for energies above 10 MV.
- Age 18 years or older at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-33 or Karnofsky (KPS) 30-100 at the time of enrollment.
- Ability to understand and the willingness to sign an IRB-approved informed consent document directly.
- Agreement to participate after reviewing the information sheet
- Radiation therapist at AHWFBCCC High Point who has treated at least one participant who enrolled on to the study and used the VR device.
Who cannot join
- Previous radiation therapy
- VR device is determined to impede the radiation dosage during the VR device simulation and treatment planning
- Participants with primary brain tumors, brain metastases, and cancer involving the sinuses, orbits, nose, or ears, are excluded from this clinical trial because the VR device may obstruct the area being treated
- Participants with uncontrolled inter-current illness including but not limited to psychiatric illness/social situations that would limit compliance with study requirements per treating radiation oncologist.
- Participants with known epilepsy, significant motion sickness, severe uncorrected visual impairment, severe uncorrected hearing impairment, or seizures, per participant report.
- Participants with skin defects, infections, or open wounds in the area where the VR device is applied (face or scalp) or in the eyes per treating radiation oncologist.
- Participants with pacemakers, internal defibrillators, hearing aid, or other implanted medical device. The Meta Quest device contains magnets and components that emit magnetic/electromagnetic fields which could affect the operation of nearby electronics and medical devices.
- Radiation Therapists:
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Atrium Health Wake Forest Baptist Hayworth Cancer Center
High Point, North Carolina, 27262
Sheri Whittington, 336-878-6107, Sheri.Whittington@Advocatehealth.org
Stephanie Parker, MS
About this study
Official title: Effectiveness of Virtual Reality in the Management of Anxiety for Patients Undergoing Radiotherapy
The purpose of this study is to evaluate the use and functionality of virtual reality (VR) during radiation therapy treatments for patients with prostate, breast, lung, or head and neck cancer.
Read the detailed description
This is a randomized controlled trial that will assess the feasibility, acceptability, tolerability, and initial clinical efficacy of using a VR device during radiation therapy for participants with prostate cancer, breast cancer, lung cancer, or head and neck cancer.
Participants will be randomized 2:1 to either the VR device intervention arm or the standard of care control arm.
Participants will undergo pre-study assessments, assessments before and after the first radiation treatment, every 6th radiation treatment, and at the end of treatment.
- Conditions
- Radiation Therapy, Virtual Reality
- Being tested
- standard of care, Virtual Reality Intervention, Radiation Therapist Survey
- Keywords
- Virtual Reality, Cancer, Radiation Therapy
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standard of careOther
Radiation therapy for prostate cancer, breast cancer, lung cancer, or head and neck cancer.
Virtual Reality InterventionOther
Participants will wear the VR headset (Meta Quest 2) during standard of care radiation therapy
Radiation Therapist SurveyOther
Radiation therapists will be asked about their experiences and proficiency with using the VR device.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Other | Standard of care radiation therapy for prostate, lung, breast cancer without using the VR headset Receives: Other: standard of care |
| Virtual Reality intervention | Other | Participants will wear the VR headset (Quest 2 by Meta) during radiation therapy Receives: Other: standard of care; Other: Virtual Reality Intervention |
| Radiation Therapists | Other | Providers that administer the VR intervention Receives: Other: Radiation Therapist Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
VR Use During Treatment
A binary variable (Yes/No) will be created for participants at the level of individual treatment visit to signify whether the participants wore the VR device for the duration of their treatment.
Measured: Periprocedural (each treatment visit)
VR Functionality
VR device functionality (0-2) will be determined at the level of individual treatment visit using the following criteria as determined by the participant and/or treatment staff:
0 = device not functional at any time during the treatment
- = device functional for part but not all of the treatment duration
- = device was functional for the duration of the treatment
Measured: Periprocedural (each treatment visit)
Secondary outcomes (2)
Anxiety - Change over time
Generalized Anxiety Disorder 7-item (GAD-7) to assess pre-existing generalized anxiety and the 23-item Radiotherapy Experience Questionnaire (RTEQ) situational unease and situational repose subscales.
Measured: GAD-7: Baseline RTEQ: Periprocedural (After first and last treatment)
Acceptability of Implementing VR
Radiation Therapist Survey (Administered to staff only)
Measured: At 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start7 May 2026
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation TherapyStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Atrium Health Wake Forest Baptist, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephanie Parker, MS, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324577
- Sponsor's protocol ID
- IRB00140668
- Other IDs
- P30CA012197, ONC-LUN-2407
- Acronym
- RELAX
- Status last verified
- Jul 2026
- First submitted
- 18 Nov 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality in the Management of Anxiety for Patients Undergoing Radiotherapy
- ClinicalTrials.gov ID
- NCT07324577
- Acronym / sponsor ID
- RELAX / IRB00140668
- Conditions
- Radiation Therapy, Virtual Reality
- Keywords
- Virtual Reality, Cancer, Radiation Therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Atrium Health Wake Forest Baptist, National Cancer Institute (NCI)
- Study start
- 7 May 2026 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the use and functionality of virtual reality (VR) during radiation therapy treatments for patients with prostate, breast, lung, or head and neck cancer.
Detailed description
This is a randomized controlled trial that will assess the feasibility, acceptability, tolerability, and initial clinical efficacy of using a VR device during radiation therapy for participants with prostate cancer, breast cancer, lung cancer, or head and neck cancer.
Participants will be randomized 2:1 to either the VR device intervention arm or the standard of care control arm.
Participants will undergo pre-study assessments, assessments before and after the first radiation treatment, every 6th radiation treatment, and at the end of treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Other | Other: standard of careStandard of care radiation therapy for prostate, lung, breast cancer without using the VR headset |
| Virtual Reality intervention | Other | Other: standard of care, Other: Virtual Reality InterventionParticipants will wear the VR headset (Quest 2 by Meta) during radiation therapy |
| Radiation Therapists | Other | Other: Radiation Therapist SurveyProviders that administer the VR intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants planned for radiation therapy for 15 or more treatments with non-neutron generating energies (10 MV or less) per study PI for prostate, breast, lung, or head and neck cancer. Neutrons have the potential to damage the VR headset device and are generated for energies above 10 MV.
- Age 18 years or older at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-33 or Karnofsky (KPS) 30-100 at the time of enrollment.
- Ability to understand and the willingness to sign an IRB-approved informed consent document directly.
- Agreement to participate after reviewing the information sheet
Key exclusion criteria (8 listed)
- Previous radiation therapy
- VR device is determined to impede the radiation dosage during the VR device simulation and treatment planning
- Participants with primary brain tumors, brain metastases, and cancer involving the sinuses, orbits, nose, or ears, are excluded from this clinical trial because the VR device may obstruct the area being treated
- Participants with uncontrolled inter-current illness including but not limited to psychiatric illness/social situations that would limit compliance with study requirements per treating radiation oncologist.
- Participants with known epilepsy, significant motion sickness, severe uncorrected visual impairment, severe uncorrected hearing impairment, or seizures, per participant report.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standard of careRadiation therapy for prostate cancer, breast cancer, lung cancer, or head and neck cancer. | Other | Standard of care, Virtual Reality intervention |
| Virtual Reality InterventionParticipants will wear the VR headset (Meta Quest 2) during standard of care radiation therapy | Other | Virtual Reality intervention |
| Radiation Therapist SurveyRadiation therapists will be asked about their experiences and proficiency with using the VR device. | Other | Radiation Therapists |
Primary outcome
VR Use During Treatment
Time frame: Periprocedural (each treatment visit)
A binary variable (Yes/No) will be created for participants at the level of individual treatment visit to signify whether the participants wore the VR device for the duration of their treatment.
VR Functionality
Time frame: Periprocedural (each treatment visit)
VR device functionality (0-2) will be determined at the level of individual treatment visit using the following criteria as determined by the participant and/or treatment staff: 0 = device not functional at any time during the treatment 1. = device functional for part but not all of the treatment duration 2. = device was functional for the duration of the treatment
2 secondary outcomes
Anxiety - Change over time
Time frame: GAD-7: Baseline RTEQ: Periprocedural (After first and last treatment)
Acceptability of Implementing VR
Time frame: At 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stephanie Parker, MS principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Intervention and Radiation Therapist Survey in people with Radiation Therapy and Virtual Reality, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheri Whittington (336-878-6107, Sheri.Whittington@Advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VR Use During Treatment (time frame: Periprocedural (each treatment visit)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.